Data updated: Mar 10, 2026
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
MOXIFLOXACIN HYDROCHLORIDE
Approved 2001-11-30
7
Indications
--
Phase 3 Trials
2
Priority Reviews
24
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2001-11-30
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER Approval History
Loading approval history...
What AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER Treats
7 FDA approvalsOriginally approved for its first indication in 2001 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals)- • Approved indication (Nov 2001)Label Letter
- • Approved indication (Feb 2003)Label Letter
- • Approved indication (May 2004) PriorityLabel Letter
- • Approved indication (Jun 2005)Label Letter
- • Approved indication (Nov 2005)Label Letter
- • Approved indication (May 2015)Label Letter
- • Approved indication (Sep 2016) PriorityLabel Letter
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.